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Clinical Trial

Glycemic Effect of Diazoxide in NAFLD

NCT: NCT05729282 · COMPLETED

NCT IDNCT05729282
StatusCOMPLETED
Start Date2023-08-01
Completion2025-09-10
SponsorColumbia University (OTHER)
First posted
Last updated

Brief Summary

The goal of this clinical trial is to compare a two-week course of diazoxide (at two different doses) and placebo in people with overweight/obesity and insulin resistance (IR) with, or at high risk for, non-alcoholic fatty liver disease (NAFLD). The main questions it aims to answer are how mitigation of compensatory hyperinsulinemia with diazoxide affects parameters of glucose and lipid metabolism (how people with IR and NAFLD respond to lowering high insulin levels so that the investigators can see what happens to how the liver handles fat and sugar). Participants will: * Take 27 doses of diazoxide (at 1 mg per kg of body weight per dose \[mpk\] or 2 mpk) or of placebo, over 14 days * Take 32 doses of heavy (deuterated) water (50 mL each) over 14 days * Have blood drawn and saliva collected after an overnight fast on four mornings over the two-week study period * Consume their total calculated daily caloric needs as divided into three meals per day * Wear a continuous glucose monitor for the two-week study period Researchers will compare fasting blood tests at intervals during the study period in participants randomized (like the flip of a coin) to diazoxide 1 mpk, diazoxide 2 mpk, or placebo, to see how the drug treatment affects plasma glucose, serum insulin, and serum lipid parameters (triglycerides, free fatty acids, and apolipoprotein B). They will also consume heavy (deuterated) water to assess de novo lipogenesis (building of new fatty acids by the liver).

Frequently Asked Questions

What is Glycemic Effect of Diazoxide in NAFLD?

Glycemic Effect of Diazoxide in NAFLD is a clinical trial registered under NCT05729282. Current status: COMPLETED.

What is the status of NCT05729282?

The current status of NCT05729282 (Glycemic Effect of Diazoxide in NAFLD) is: COMPLETED.

When did Glycemic Effect of Diazoxide in NAFLD start?

Glycemic Effect of Diazoxide in NAFLD started on 2023-08-01.

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Official Source

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Data sourced from ClinicalTrials.gov API. For the most current status, refer to the official record.

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